Kissei Pharmaceutical Submits New Drug Application for Acute Myeloid Leukemia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 6 days ago
0mins
Kissei Pharmaceutical announced that the company has submitted a new drug application for manufacturing and marketing approval in Japan for "olutasidenib," indicated for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation. "Olutasidenib was approved in the United States in December 2022 for the treatment of relapsed or refractory AML with a susceptible IDH1 mutation and is sold by Rigel. In Taiwan, our licensee, Orient EuroPharma Co., Ltd. , is developing olutasidenib. Kissei is focused on researching and developing new drugs for rare diseases and conditions that lack sufficient treatments. We are committed to providing new treatment options for patients suffering from these diseases. The impact of this submission on our consolidated financial forecast for the fiscal year ending March 31, 2027, has been incorporated into the forecast disclosed on May 11," the company stated.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy RIGL?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on RIGL
Wall Street analysts forecast RIGL stock price to rise
4 Analyst Rating
2 Buy
2 Hold
0 Sell
Moderate Buy
Current: 29.860
Low
38.00
Averages
52.00
High
71.00
Current: 29.860
Low
38.00
Averages
52.00
High
71.00
About RIGL
Rigel Pharmaceuticals, Inc. is a biotechnology company. The Company is engaged in developing and providing therapies for patients with hematologic disorders and cancer. It focuses on products that address signaling pathways that are critical to disease mechanisms. Its products include TAVALISSE, REZLIDHIA, and GAVRETO. TAVALISSE is an oral spleen tyrosine kinase inhibitor for the treatment of adult patients with chronic immune thrombocytopenia. REZLIDHIA is used for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild type rearranged during transfection (RET) and oncogenic RET fusions. It is used for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Rigel Pharmaceuticals to Present at Jefferies Global Healthcare Conference
- Presentation Schedule: Rigel Pharmaceuticals' CEO Raul Rodriguez will present a company overview at the Jefferies Global Healthcare Conference on June 3, 2026, at 8:45 a.m. ET in New York, aiming to enhance investor understanding of the company's operations.
- Webcast Access: Investors can access the live webcast and archived recording of the presentation through the Investor Relations section of Rigel's website, ensuring they connect prior to the start to allow for any necessary software downloads, thereby improving investor engagement.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on developing innovative therapies for hematologic disorders and cancer, dedicated to significantly improving patient quality of life, showcasing its expertise in the biotechnology sector.
- Pipeline Information: Rigel not only has marketed products but is also actively advancing a pipeline of potential products, further solidifying its position in the biopharmaceutical industry and attracting more investor interest in its future growth potential.
See More
Rigel Pharmaceuticals Presents GAVRETO Phase 3 Data at ASCO 2026
- Clinical Trial Results: Rigel Pharmaceuticals will present the final data from the Phase 3 AcceleRET-Lung trial of GAVRETO (pralsetinib) for RET fusion-positive non-small cell lung cancer (NSCLC) at the 2026 ASCO Annual Meeting, which is expected to enhance its market position in oncology treatment.
- Multiple Data Presentations: In addition to the oral presentation of GAVRETO, both ASCO and the European Hematology Association (EHA) will feature data on REZLIDHIA (olutasidenib) for relapsed or refractory acute myeloid leukemia (AML), further validating its efficacy as a treatment option.
- Market Demand Response: With over 229,000 new lung cancer diagnoses projected in the U.S. in 2026, and non-small cell lung cancer accounting for 77% of all cases, GAVRETO's potential as a first-line treatment highlights its market opportunity to meet increasing patient needs.
- Strategic Significance: The CEO of Rigel emphasized that the presentations at ASCO underscore the clinical relevance of their oncology portfolio, indicating the company's commitment to developing targeted therapies for difficult-to-treat cancers, thereby improving patient quality of life and driving long-term growth.
See More
Rigel Pharmaceuticals to Present GAVRETO and REZLIDHIA Data at ASCO Annual Meeting
- Clinical Trial Data Presentation: Rigel Pharmaceuticals will present final data from the Phase 3 AcceleRET-Lung trial of GAVRETO (pralsetinib) at the 2026 ASCO Annual Meeting, demonstrating superior progression-free survival (PFS) compared to standard care, highlighting its clinical utility in RET fusion-positive NSCLC.
- Safety Analysis: In the AcceleRET-Lung trial, 30% of patients in the GAVRETO group experienced death, with 7.4% due to infections, indicating a need for enhanced monitoring of infection risks to ensure patient safety during treatment.
- Efficacy Validation of REZLIDHIA: In a real-world study of relapsed or refractory (R/R) IDH1-mutated acute myeloid leukemia (AML) patients, REZLIDHIA demonstrated a 60.8% complete response rate and a median response duration of 30.3 months, reinforcing its position as an effective treatment option.
- Future Treatment Strategies: The findings suggest that earlier sequencing of REZLIDHIA may optimize patient outcomes, emphasizing the importance of strategic drug ordering in addressing the challenges faced by relapsed AML patients.
See More
Rigel Pharmaceuticals to Present at RBC Capital Markets Global Healthcare Conference
- Conference Presentation: Rigel Pharmaceuticals' CFO Dean Schorno will present a company overview at the RBC Capital Markets Global Healthcare Conference on May 19, 2026, at 9:30 a.m. ET in New York, highlighting its innovative therapies for hematologic disorders and cancer.
- Webcast Access: Investors can access the live webcast and archived recording through the Investor Relations section of Rigel's website, ensuring they connect prior to the start of the live event for any necessary software downloads to enhance participation.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on discovering and developing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer, showcasing its expertise and market potential in the biotechnology sector.
- Investor Contact Information: Investors and media can reach out through the provided contact details for timely inquiries, ensuring transparency and effective communication, which strengthens the interaction between the company and its investors.
See More
Rigel Partners with Arvinas and Pfizer for Breast Cancer Treatment
- FDA Approval: Vepdegestrant, branded as Veppanu, received FDA approval earlier this month, becoming the only FDA-approved oral PROTAC therapy, which is expected to drive Rigel's cancer treatment portfolio expansion and enhance market competitiveness.
- Financial Gains from Agreement: Rigel will receive $70 million upfront and an additional $15 million upon completion of transition activities, along with potential future milestone payments of up to $320 million, significantly improving the company's financial outlook and investor confidence.
- Positive Stock Reaction: Rigel's shares surged over 15% following the announcement of the agreement, reflecting investor optimism regarding the new drug's market potential and indicating the company's growth prospects in oncology.
- Clinical Data Support: Veppanu demonstrated a 43% reduction in disease progression risk in Phase 3 studies, with a median progression-free survival of five months compared to 2.1 months for the comparator drug Fulvestrant, highlighting its significant therapeutic advantage.
See More
Arvinas and Rigel Reach Licensing Agreement for Breast Cancer Therapy
- Agreement Reached: Arvinas (ARVN) and Pfizer (PFE) have finalized an agreement to sell global licensing rights for their jointly developed breast cancer therapy, Veppanu, to Rigel (RIGL), marking a significant advancement in breast cancer treatment.
- Cash Inflow: Rigel (RIGL) will provide $70 million upfront to Arvinas (ARVN) and Pfizer (PFE), along with an additional $15 million contingent on specific development and manufacturing milestones, significantly enhancing the funding capabilities for ongoing R&D activities.
- Milestone Payments: The agreement includes up to $320 million in milestone payments and tiered royalties on net sales ranging from the mid-teens to mid-20s, indicating substantial market potential for the therapy and promising long-term revenue for the partners.
- Global Market Expansion: Rigel (RIGL) will receive global rights to Veppanu, including sublicensing rights in overseas territories, which not only broadens market reach but also provides Arvinas (ARVN) and Pfizer (PFE) with additional revenue streams, further solidifying their positions in the global biopharmaceutical market.
See More
Rigel Pharmaceuticals to Present at Jefferies Global Healthcare Conference
- Presentation Schedule: Rigel Pharmaceuticals' CEO Raul Rodriguez will present a company overview at the Jefferies Global Healthcare Conference on June 3, 2026, at 8:45 a.m. ET in New York, aiming to enhance investor understanding of the company's operations.
- Webcast Access: Investors can access the live webcast and archived recording of the presentation through the Investor Relations section of Rigel's website, ensuring they connect prior to the start to allow for any necessary software downloads, thereby improving investor engagement.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on developing innovative therapies for hematologic disorders and cancer, dedicated to significantly improving patient quality of life, showcasing its expertise in the biotechnology sector.
- Pipeline Information: Rigel not only has marketed products but is also actively advancing a pipeline of potential products, further solidifying its position in the biopharmaceutical industry and attracting more investor interest in its future growth potential.
See More
Rigel Pharmaceuticals Presents GAVRETO Phase 3 Data at ASCO 2026
- Clinical Trial Results: Rigel Pharmaceuticals will present the final data from the Phase 3 AcceleRET-Lung trial of GAVRETO (pralsetinib) for RET fusion-positive non-small cell lung cancer (NSCLC) at the 2026 ASCO Annual Meeting, which is expected to enhance its market position in oncology treatment.
- Multiple Data Presentations: In addition to the oral presentation of GAVRETO, both ASCO and the European Hematology Association (EHA) will feature data on REZLIDHIA (olutasidenib) for relapsed or refractory acute myeloid leukemia (AML), further validating its efficacy as a treatment option.
- Market Demand Response: With over 229,000 new lung cancer diagnoses projected in the U.S. in 2026, and non-small cell lung cancer accounting for 77% of all cases, GAVRETO's potential as a first-line treatment highlights its market opportunity to meet increasing patient needs.
- Strategic Significance: The CEO of Rigel emphasized that the presentations at ASCO underscore the clinical relevance of their oncology portfolio, indicating the company's commitment to developing targeted therapies for difficult-to-treat cancers, thereby improving patient quality of life and driving long-term growth.
See More
Rigel Pharmaceuticals to Present GAVRETO and REZLIDHIA Data at ASCO Annual Meeting
- Clinical Trial Data Presentation: Rigel Pharmaceuticals will present final data from the Phase 3 AcceleRET-Lung trial of GAVRETO (pralsetinib) at the 2026 ASCO Annual Meeting, demonstrating superior progression-free survival (PFS) compared to standard care, highlighting its clinical utility in RET fusion-positive NSCLC.
- Safety Analysis: In the AcceleRET-Lung trial, 30% of patients in the GAVRETO group experienced death, with 7.4% due to infections, indicating a need for enhanced monitoring of infection risks to ensure patient safety during treatment.
- Efficacy Validation of REZLIDHIA: In a real-world study of relapsed or refractory (R/R) IDH1-mutated acute myeloid leukemia (AML) patients, REZLIDHIA demonstrated a 60.8% complete response rate and a median response duration of 30.3 months, reinforcing its position as an effective treatment option.
- Future Treatment Strategies: The findings suggest that earlier sequencing of REZLIDHIA may optimize patient outcomes, emphasizing the importance of strategic drug ordering in addressing the challenges faced by relapsed AML patients.
See More
Rigel Pharmaceuticals to Present at RBC Capital Markets Global Healthcare Conference
- Conference Presentation: Rigel Pharmaceuticals' CFO Dean Schorno will present a company overview at the RBC Capital Markets Global Healthcare Conference on May 19, 2026, at 9:30 a.m. ET in New York, highlighting its innovative therapies for hematologic disorders and cancer.
- Webcast Access: Investors can access the live webcast and archived recording through the Investor Relations section of Rigel's website, ensuring they connect prior to the start of the live event for any necessary software downloads to enhance participation.
- Company Background: Founded in 1996 and based in South San Francisco, California, Rigel Pharmaceuticals focuses on discovering and developing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer, showcasing its expertise and market potential in the biotechnology sector.
- Investor Contact Information: Investors and media can reach out through the provided contact details for timely inquiries, ensuring transparency and effective communication, which strengthens the interaction between the company and its investors.
See More
Rigel Partners with Arvinas and Pfizer for Breast Cancer Treatment
- FDA Approval: Vepdegestrant, branded as Veppanu, received FDA approval earlier this month, becoming the only FDA-approved oral PROTAC therapy, which is expected to drive Rigel's cancer treatment portfolio expansion and enhance market competitiveness.
- Financial Gains from Agreement: Rigel will receive $70 million upfront and an additional $15 million upon completion of transition activities, along with potential future milestone payments of up to $320 million, significantly improving the company's financial outlook and investor confidence.
- Positive Stock Reaction: Rigel's shares surged over 15% following the announcement of the agreement, reflecting investor optimism regarding the new drug's market potential and indicating the company's growth prospects in oncology.
- Clinical Data Support: Veppanu demonstrated a 43% reduction in disease progression risk in Phase 3 studies, with a median progression-free survival of five months compared to 2.1 months for the comparator drug Fulvestrant, highlighting its significant therapeutic advantage.
See More
Arvinas and Rigel Reach Licensing Agreement for Breast Cancer Therapy
- Agreement Reached: Arvinas (ARVN) and Pfizer (PFE) have finalized an agreement to sell global licensing rights for their jointly developed breast cancer therapy, Veppanu, to Rigel (RIGL), marking a significant advancement in breast cancer treatment.
- Cash Inflow: Rigel (RIGL) will provide $70 million upfront to Arvinas (ARVN) and Pfizer (PFE), along with an additional $15 million contingent on specific development and manufacturing milestones, significantly enhancing the funding capabilities for ongoing R&D activities.
- Milestone Payments: The agreement includes up to $320 million in milestone payments and tiered royalties on net sales ranging from the mid-teens to mid-20s, indicating substantial market potential for the therapy and promising long-term revenue for the partners.
- Global Market Expansion: Rigel (RIGL) will receive global rights to Veppanu, including sublicensing rights in overseas territories, which not only broadens market reach but also provides Arvinas (ARVN) and Pfizer (PFE) with additional revenue streams, further solidifying their positions in the global biopharmaceutical market.
See More
